ISO 13485 Certification & CE Mark Certification

In December of 2002, the BBI facility in West Bridgewater, MA was awarded ISO 13485 certification by G-MED. The ISO 13485 is an International Standard for Quality Management Systems more rigorous than ISO 9001 and designed for medical device manufacturers.

Beginning in 2001,SeraCare | BBI undertook a commitment to seek CE mark certification for our control products. SeraCare | BBI continues to be the leader among U.S. quality control manufacturers in gaining CE marking for products used by our worldwide customer base. As of April 2005 over 50 SeraCare | BBI products haved earned the right to bear the CE mark.

The requirements for gaining CE mark certification (IVD Directive 98/79/CE Article 1) list quality controls such as ACCURUN ^® as medical devices, but do not include quality control panels. Therefore, CE mark status is not required for panels (qualification panels, seroconversion panels, performance panels, etc).

The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives. The letters "CE" are an abbreviation of Conformité Européenne, French for European conformity. Without the CE marking, and thus without complying with the conformity provisions of the Directives, the product may not be placed in the market or put into service in the member states of the European Union. Thus, CE marking can be regarded as the product's trade passport for Europe. CE indicates conformity with mandatory European safety requirements. European conformity is certified by following clear and understandable procedures, the so-called 'conformity assessment procedures'.